Knee OsteoarthritisNCT04044612
Effect of Knee Bracing on Improving Pain & Disability
A study testing Medial Unloader Brace in people with Knee Osteoarthritis, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
The overall purpose of the proposed pilot study is to establish the feasibility of conducting a clinical trial by evaluating the preliminary effects of 8 weeks of knee bracing on physiological measures of self-reported pain and disability, physical performance, physical activity, as well as femoral cartilage… Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Medial Unloader Brace
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2018to 31 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants must:
- have a physician diagnosis of knee OA in the medial compartment and exhibit symptomatic knee OA, which the investigators will define as a normalized, person based, Western Ontario and McMaster Universities Arthritis Index (WOMAC) function subscale score > 31 (out of 100 points, indicating most dysfunction).
- have had a knee radiograph taken within the previous 6 months.
- be between the ages of 40 and 75 years old will be included.
Who cannot join
- Participants will be excluded if they have:
- been diagnosed with a cardiovascular condition restricting exercise;
- had a corticosteroid or hyaluronic acid injection in the involved knee in the previous 2 weeks;
- a pacemaker;
- a neurodegenerative condition;
- rheumatoid arthritis;
Show all 15Show fewer
- cancer;
- neural sensory dysfunction over the knee;
- a BMI over 35;
- history of lower extremity orthopaedic surgery in the past year;
- a history of a traumatic knee injury in the past 6 months;
- any history of a total knee arthroplasty in either extremity; or
- a diagnosed, non-reconstructed knee ligament tear.
- the need of an assistive device to walk.
- The investigators will also exclude pregnant women, as well as women who are trying to get pregnant or plan to get pregnant during the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Motion Science Institute
Chapel Hill, North Carolina, 27599
About this study
Official title: Effect of Knee Bracing on Improving Pain & Disability, Physical Performance, Physical Activity and Femoral Cartilage Deformation in Individuals With Medial Compartment Knee Osteoarthritis
The overall purpose of the proposed pilot study is to establish the feasibility of conducting a clinical trial by evaluating the preliminary effects of 8 weeks of knee bracing on physiological measures of self-reported pain and disability, physical performance, physical activity, as well as femoral cartilage deformation in individuals with medial compartment knee osteoarthritis (OA). The investigators will recruit 36 symptomatic knee OA patients for the pilot study. The investigators will evaluate a class of braces (two different models will be used) designed to correct genu varum. The purpose of the study is to evaluate changes in these novel outcomes following the use of a class of braces used to reduce medial tibiofemoral compartment compression used for 8 weeks. This pilot study will inform a larger future trial to determine the efficacy of bracing on decreasing disability and disease progression in patients with knee osteoarthritis.
- Conditions
- Knee Osteoarthritis
- Being tested
- Medial Unloader Brace
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medial Unloader BraceOther
medial knee unloader braces use a three point bending system to increase space in the medial tibiofemoral compartment during weight bearing
| Study group | Role | What they receive |
|---|---|---|
| Medial Unloader Brace | Experimental | Not described Receives: Other: Medial Unloader Brace |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage Change in WOMAC Function score from Baseline to 8 weeks
The Western Ontario and McMasters Osteoarthritis Index (WOMAC) is a self-reported measure of disability. The physical function consists of 17 items and asks about the magnitude of difficulty when ascending and descending stairs, rising from sitting, standing, bending, walking, getting in/out of a car, shopping, putting on and taking off socks, rising from bed, lying in bed, getting in and out of the bath, sitting, getting on and off the toilet, completing heavy household duties, and completing light household duties. Each item is presented in a 5 point Likert-type format and uses the following descriptors for possible answer choices none, mild moderate, severe, and extreme. Each descriptor corresponds to an ordinal scale of 0-4. The scores are summed for the items in each subscale, with a total possible range from 0-68. Higher scores indicate greater amounts of functional limitations.
Measured: Baseline, Week 8 (Followup)
Percentage Change in Physical Activity Scale for the Elderly from Baseline to 8 weeks
Physical Activity Scale for the Elderly (PASE) scores are calculated from weights and frequency values for each of 12 types of activity. Responses to the first question about sitting activities are not scored. The scale is continuous with higher scores indicating greater physical activity
Measured: Baseline, Week 8 (Followup)
Percentage Change in 30-s chair-stand test from Baseline to 8 weeks
The number of times that an individual can sit and stand in 30 seconds.
Measured: Baseline, Week 8 (Followup)
Percentage Change in 20 meter fast-paced walk test from Baseline to 8 weeks
The investigators will time the amount of seconds it takes to walk 20 meters.
Measured: Baseline, Week 8 (Followup)
Percentage Change in Stair-climb test from Baseline to 8 weeks
The investigators will time the amount of seconds it takes to walk up and down a flight of stairs.
Measured: Baseline, Week 8 (Followup)
Percentage Change in Femoral Cartilage Cross-sectional area from Baseline to 8 weeks
The investigators will measure the amount of cartilage cross-sectional area on the anterior femur before and after 3000 steps of walking. A greater change in cross-sectional area is determined to be more more cartilage deformation.
Measured: Baseline, Week 8 (Followup)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2019
- Study start1 Dec 2018
- Primary completion31 Mar 2020
- Study completion31 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- American Orthotic and Prosthetic Association
- Responsible party
- Sponsor
- Investigators
- Brian Pietrosimone, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04044612
- Sponsor's protocol ID
- 18-2363
- Status last verified
- Mar 2021
- First submitted
- 1 Aug 2019
- Last updated
- 8 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Knee Bracing on Improving Pain & Disability, Physical Performance, Physical Activity and Femoral Cartilage Deformation in Individuals With Medial Compartment Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT04044612
- Acronym / sponsor ID
- 18-2363
- Conditions
- Knee Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- American Orthotic and Prosthetic Association
- Study start
- 1 Dec 2018 (actual)
- Primary completion
- 31 Mar 2020 (actual)
- Study completion
- 31 Mar 2020 (actual)
- First posted
- 5 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The overall purpose of the proposed pilot study is to establish the feasibility of conducting a clinical trial by evaluating the preliminary effects of 8 weeks of knee bracing on physiological measures of self-reported pain and disability, physical performance, physical activity, as well as femoral cartilage deformation in individuals with medial compartment knee osteoarthritis (OA). The investigators will recruit 36 symptomatic knee OA patients for the pilot study. The investigators will evaluate a class of braces (two different models will be used) designed to correct genu varum. The purpose of the study is to evaluate changes in these novel outcomes following the use of a class of braces used to reduce medial tibiofemoral compartment compression used for 8 weeks. This pilot study will inform a larger future trial to determine the efficacy of bracing on decreasing disability and disease progression in patients with knee osteoarthritis.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Medial Unloader Brace | Experimental | Other: Medial Unloader Brace |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- have a physician diagnosis of knee OA in the medial compartment and exhibit symptomatic knee OA, which the investigators will define as a normalized, person based, Western Ontario and McMaster Universities Arthritis Index (WOMAC) function subscale score > 31 (out of 100 points, indicating most dysfunction).
- have had a knee radiograph taken within the previous 6 months.
- be between the ages of 40 and 75 years old will be included.
Key exclusion criteria (15 listed)
- been diagnosed with a cardiovascular condition restricting exercise;
- had a corticosteroid or hyaluronic acid injection in the involved knee in the previous 2 weeks;
- a pacemaker;
- a neurodegenerative condition;
- rheumatoid arthritis;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medial Unloader Bracemedial knee unloader braces use a three point bending system to increase space in the medial tibiofemoral compartment during weight bearing | Other | Medial Unloader Brace |
Primary outcome
Percentage Change in WOMAC Function score from Baseline to 8 weeks
Time frame: Baseline, Week 8 (Followup)
The Western Ontario and McMasters Osteoarthritis Index (WOMAC) is a self-reported measure of disability. The physical function consists of 17 items and asks about the magnitude of difficulty when ascending and descending stairs, rising from sitting, standing, bending, walking, getting in/out of a car, shopping, putting on and taking off socks, rising from bed, lying in bed, getting in and out of the bath, sitting, getting on and off the toilet, completing heavy household duties, and completing light household duties. Each item is presented in a 5 point Likert-type format and uses the following descriptors for possible answer choices none, mild moderate, severe, and extreme. Each descriptor corresponds to an ordinal scale of 0-4. The scores are summed for the items in each subscale, with a total possible range from 0-68. Higher scores indicate greater amounts of functional limitations.
Percentage Change in Physical Activity Scale for the Elderly from Baseline to 8 weeks
Time frame: Baseline, Week 8 (Followup)
Physical Activity Scale for the Elderly (PASE) scores are calculated from weights and frequency values for each of 12 types of activity. Responses to the first question about sitting activities are not scored. The scale is continuous with higher scores indicating greater physical activity
Percentage Change in 30-s chair-stand test from Baseline to 8 weeks
Time frame: Baseline, Week 8 (Followup)
The number of times that an individual can sit and stand in 30 seconds.
Percentage Change in 20 meter fast-paced walk test from Baseline to 8 weeks
Time frame: Baseline, Week 8 (Followup)
The investigators will time the amount of seconds it takes to walk 20 meters.
Percentage Change in Stair-climb test from Baseline to 8 weeks
Time frame: Baseline, Week 8 (Followup)
The investigators will time the amount of seconds it takes to walk up and down a flight of stairs.
Percentage Change in Femoral Cartilage Cross-sectional area from Baseline to 8 weeks
Time frame: Baseline, Week 8 (Followup)
The investigators will measure the amount of cartilage cross-sectional area on the anterior femur before and after 3000 steps of walking. A greater change in cross-sectional area is determined to be more more cartilage deformation.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2021.
- Individual participant dataSharing planned: Yes. Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brian Pietrosimone principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medial Unloader Brace in people with Knee Osteoarthritis, run by University of North Carolina, Chapel Hill at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage Change in WOMAC Function score from Baseline to 8 weeks (time frame: Baseline, Week 8 (Followup)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2021.